Timing of breast cancer surgery in relation to menstrual cycle phase: no effect on 3-year prognosis: The ITS Study

Abstract

The effect of breast cancer surgery timing during the menstrual cycle on prognosis remains controversial. We conducted a multicentre prospective study to establish whether timing of interventions influences prognosis. We report 3-year overall and disease-free survival (OS/DFS) results for ‘primary analysis’ patients (regular cycles, no oral contraceptives within previous 6 months). Data were collected regarding timing of interventions in relation to patients’ last menstrual period (LMP) and first menstrual period after surgery (FMP). Hormone profiles were also measured. Cox's proportional hazards model incorporated LMP in continuous form. Exploratory analyses used menstrual cycle categorisations of Senie, Badwe and Hrushesky. Hormone profiles with LMP and FMP data were also used to define menstrual cycle phase. Four hundred and twelve ‘primary analysis’ patients were recruited. Three-year OS from first surgery was 90.7, 95% confidence interval (CI) [87.9, 93.6%]. Menstrual cycle according to LMP was not statistically significant (OS: hazard ratio (HR)=1.02, 95%CI [0.995,1.042], P=0.14; DFS: HR=1.00, 95%CI [0.980,1.022], P=0.92). Timing of surgery in relation to menstrual cycle phase had no significant impact on 3-year survival. This may be due to 97% of patients receiving some form of adjuvant therapy. Survival curves to 10 years indicate results may remain true for longer-term survival.